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A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray

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ClinicalTrials.gov Identifier: NCT00793858
Recruitment Status : Withdrawn (Cost prohibitive and company withdrew support.)
First Posted : November 19, 2008
Last Update Posted : June 7, 2013
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
University of Chicago

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patients (18 Years or Older) With Documented Perennial Allergic Rhinitis (PAR).
Study Start Date : February 2009
Estimated Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ciclesonide
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 1
placebo in left nostril, isotonic ciclesonide in right
 Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
Active Comparator: 2
hypotonic ciclesonide in left nostril, placebo in right
 Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
Active Comparator: 3
hypotonic ciclesonide in right and left nostrils
 Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
Active Comparator: 4
isotonic ciclesonide in both right and left nostrils
 Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
Placebo Comparator: 6
placebo in both right and left nostrils
 Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril
Active Comparator: 5
isotonic ciclesonide in left nostril and hypotonic ciclesonide in right
 Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. levels of ciclesonide in biopsy tissue [ Time Frame: 2 hours post study drug administration ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females 18 years of age or older.
  2. History of perennial allergic rhinitis for at least 1 year prior to screening.
  3. Positive skin test to perennial allergen.

Exclusion Criteria:

  1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
  2. Pregnant or lactating women.
  3. Upper respiratory infection within 14 days of study start.
  4. Active asthma requiring treatment with inhaled or systemic steroids.
  5. Use of any form of nasal spray during the previous month.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793858


Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Sunovion
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00793858     History of Changes
Other Study ID Numbers: 16651A (SEP 1)
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Ciclesonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents